Rayvolve

Primary DI
03770018071015
Brand
Rayvolve
Company
AZMED
Model
2
Device description
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only.Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types.(Variant : Full Cloud)
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBSRadiological Computer Assisted Detection/Diagnosis Software For FractureRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220164000RayvolveAzmed Sas2022-06-02QBS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770018071015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770018071015037700180710153770018071015

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
271425256
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770018071060Rayvolve42024-10-11
03770018071077Rayvolve42024-10-11
03770018071084Rayvolve42024-10-11
03770018071008Rayvolve22024-06-10
03770018071022Rayvolve22024-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B621ICOBRAINARIA1X2Y0icobrain ariaicometrix NVQBS2025-10-24
03770024774047TechCare TraumaMILVUEQBS2025-03-31
B621ICOBRAINARIA1X1Y0icobrain ariaicometrix NVQBS2025-02-18
03770018071060RayvolveAZMEDQBS2024-10-11
03770018071077RayvolveAZMEDQBS2024-10-11
03770018071084RayvolveAZMEDQBS2024-10-11
03770018071008RayvolveAZMEDQBS2024-06-10
03770018071022RayvolveAZMEDQBS2024-03-18
00195278789365Critical Care SuiteGE Medical Systems, L.L.C.QBS2023-10-19
03770020839085BoneViewGLEAMERQBS2023-03-16
03770020839009BoneViewGLEAMERQBS2022-04-20
00852491008016FractureDetect (FX)Imagen Technologies, Inc.QBS2021-04-12